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Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial.
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Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.
: SCTV01E is a tetravalent recombinant COVID-19 vaccine authorized for emergency use in China for adults 18 years and older but not for those under 18. : This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children and adolescents aged 3 to 17 years, to establish immunobridging with that observed in adults from the efficacy pivotal trial (NCT05308576). : Participants were randomly assigned to receive either 30 µg of SCTV01E or a placebo.
View Article and Find Full Text PDFImmunogenicity, Efficacy, and Effectiveness of Two-Dose and Shorter Schedules of Hepatitis E Vaccine: A Systematic Review.
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December 2024
Department of Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India.
: Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in adults. The schedule for HEV 239, the only approved anti-HEV vaccine, consists of three doses at 0, 1, and 6 months, which is unsuitable for use in emergency and outbreak situations where quick protection is desired. We, therefore, undertook a systematic review of data on immunogenicity, efficacy, and effectiveness of alternative accelerated schedules.
View Article and Find Full Text PDFImpact of disintegrants on rheological properties and printability in SSE 3D printing of immediate-release formulations.
Eur J Pharm Sci
January 2025
RAPSODEE, IMT Mines Albi, CNRS, University of Toulouse, 81013 Albi, France.
This study investigates the effects of disintegrants sodium starch glycolate (SSG) and crospovidone (CP) on the printability, rheological properties, and disintegration time of agar and hydroxypropyl methylcellulose (HPMC)-based formulations designed for semi-solid extrusion. Printability was assessed by measuring the dimensional accuracy of manually extruded filaments. Rheological analysis was performed using oscillatory measurements.
View Article and Find Full Text PDFEffect of Food Intake or Coadministration With an Acid-Reducing Agent on Lenacapavir Pharmacokinetics Following Oral Administration.
Clin Pharmacol Drug Dev
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Gilead Sciences, Inc., Foster City, CA, USA.
Lenacapavir is a potent, long-acting HIV-1 capsid inhibitor used in combination with other antiretrovirals to treat HIV-1 infection. The pharmacokinetics of orally administered drugs may be affected by food intake or coadministration of acid-reducing agents (ARA). Two Phase 1 studies were conducted on healthy participants to evaluate the effect of food and the impact of the histamine H-receptor antagonist famotidine in parallel cohorts.
View Article and Find Full Text PDFImmunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies.
Hum Vaccin Immunother
December 2025
Merck & Co, Inc, Rahway, NJ, USA.
Post hoc analyses of 9-valent human papillomavirus (9vHPV) vaccine immunogenicity were conducted in five Phase 3 studies that enrolled males. Month 7 antibody geometric mean titers (GMTs) after three 9vHPV vaccine doses were analyzed in 10,024 males/females aged 16-26 years from studies 001 (NCT00543543), 002 (NCT00943722), 003 (NCT01651949), and 020 (NCT02114385). Covariates considered were age, gender, sexual orientation, region of residence, and race.
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